Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial

I-TECH21

This is a multicenter study, which is aimed to investigate the efficacy of the Ivermectin drug in high risk COVID-19 patients. This study will compare Ivermectin treatment efficacy with standard of care alone. Target cohort is mild to moderate symptomatic Covid-19 (Stage 2-3), high risk patients aged 50 years and above with comorbidity, who presented to hospitals within first 7 days of illness.

2021-05-31

2021-10-31

2021-10-31

Completed

Early phase I

500

Inclusion Criteria: 1. RT-PCR or antigen test confirmed COVID-19 cases 2. Aged 50 years and above,with at least one co-morbidities\* 3. Within the first 7 days of illness (from symptom onset) 4. Mild to moderate clinical severity Exclusion Criteria: 1. Asymptomatic stage 1 patients 2. Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due to preexisting disease, eg. COAD or pulmonary fibrosis) 3. Patients who need oxygen supplements 4. Patients with concomitant bacterial, fungal, parasitic or other viral infections prior to enrollment. 5. Patients with severe hepatic impairment (\>Grade 3: ALT \>10 times of upper normal limit) 6. Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others). 7. Pregnant or nursing women. 8. Female patients of reproductive age who cannot consent to contraceptive use of oral contraceptives, mechanical contraceptives such as intrauterine devices or barrier devices (pessaries, condoms), or a combination of these devices from the start of ivermectin administration to 7 days after the end of ivermectin administration. 9. Male patient who has female partner of reproductive age and he cannot agree to use contraception from the start of ivermectin treatment till 7 days after treatment. 10. Patients receiving chemotherapy 11. Patients who received interferon or drugs with reported antiviral activity against COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment. 12. Patients in whom this episode of infection is a recurrence or reinfection of COVID- 19. 13. Patients who have previously received ivermectin. 14. Patient receiving warfarin or any medications known to interact with ivermectin. 15. Acute medical or surgical emergency (eg. DKA/MI/stroke). 16. Other patients judged ineligible by the principal investigator or sub-investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multicenter, open-label, randomized controlled clinical trial involving COVID-19 designated hospitals in Malaysia. Patients are randomized at ratio of 1:1 to groups receiving ivermectin for 5 days plus standard-of-care versus standard-of-care only. Patients will be assigned to stratified randomized treatments based on a central, computer-generated randomization scheme coordinated by an independent third party. Based on national guidelines, all high risk COVID-19 patients will be admitted to hospitals, and allow discharge once criteria met', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 500, 'type': 'ACTUAL'}}

2023-06-01